WASHINGTON -- A Senate bill that would create a permanentbioethics advisory board within the Department of Health andHuman Services to review all National Institutes of Health(NIH) grant proposals returned to the front burner and drewfire from the Biotechnology Industry Organization (BIO).

Under current law, the HHS secretary can review NIH grantsonly in special cases.

The bill, S. 1042, has languished since Sen. Mark Hatfield, R-Ore., introduced it in May. It re-emerged last Thursday at ahearing on "Biomedical Ethics in U.S. Public Policy" beforeMassachusetts Democrat Edward Kennedy's Labor and HumanResources Committee. The hearing coincided with the release ofan Office of Technology Assessment (OTA) report by the sametitle.

Following the committee's rejection of a request by BIO totestify, the trade organization sent a letter to Kennedy. In theletter, dated Oct. 12, Chuck Ludlam, BIO's vice president forgovernment affairs, wrote: "The proposed bill gives apermanent ethics advisory board authority to not only denyfunding for specific projects but also to deny funding to broadclasses of biotechnology research. For instance, the permanentethics board ... could ban or place a 'moratorium' on genetherapy."

The bill is unnecessary, according to Ludlam's letter and a five-page analysis by BIO because most of its prescriptions arealready required by law. Section 101 of the NIHReauthorization Act requires bioethical review of research onhuman subjects by the Institutional Review Board or throughtechnical and scientific peer review. But unlike the Hatfield bill,this section severely limits the HHS secretary's authority towithhold funds when research has been approved.

In addition, the Senate bill's method of appointing members tothe proposed ethics board "would open up much greateropportunities for politics to override scientific or even ethicalconsiderations," BIO charged. The president, the speaker of theHouse "in consultation with the minority leader," and theSenate majority leader "in consultation with the minorityleader" would each appoint five members.

"It is likely, for example, that Senator Hatfield, as the rankingRepublican on the Senate Appropriations Committee, would beable to influence or control at least one appointment to thepermanent board," Ludlam wrote.

Previous successful national bioethics commissions have been"relatively free of political interference, had flexibility inaddressing issues, were open in their process anddissemination of findings, and were comprised of a diversegroup of individuals who were generally free of ideology andwho had wide ranging expertise, Robyn Nishimi, a seniorassociate in the OTA and coordinator of the agency's report,testified at Thursday's hearing.

Nonetheless, a federal commission would be useful, saidAlexander Capron, professor of law and medicine at theUniversity of Southern California, who is also a member of theRecombinant DNA Advisory Committee (RAC).

Courts confronting ethical issues, he testified, "frequently ...have included in their decisions in these cases (involving,typically, issues of death and dying and issues of assistedreproduction) a heartfelt plea for guidance from others; wheresuch pleas have been less noticeable is precisely in those areaswhere past efforts by (previous national commissions) haveprovided just the sort of guidance the courts have needed."

Furthermore, a national commission could address "the largerissues of genetic enhancement and germ-line therapy," whichbodies such as RAC, with more immediate responsibilities,have had to ignore, said Capron.

A commission "should have a broad mandate at the level ofpolicy and general guidance," but contrary to S. 1042, "with noresponsibility to review the ethical acceptability of individualprojects," Capron said. However, he called for reinstatement ofthe Ethics Advisory Board of HHS for that purpose.

"The issues interrelate, Capron explained, and it is importantthat (staff) be concerned about the possible implications oftheir conclusions in one area for other areas lest they be eitherunintentionally blinkered in their outlook or willfullyparochial."

-- David C. Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.